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用无细胞百日咳抗原配制的吸附精制百白破制剂的特性和人群反应及血清学效果
引用本文:张嘉铭,刘德铮,王瑛,肖詹蓉,李万臣,杨景芳,周云冲,傅惠兰,丁兆松,侯启明,关瑛,祖涛,周安群,赵金锁,凌国荣.用无细胞百日咳抗原配制的吸附精制百白破制剂的特性和人群反应及血清学效果[J].粉末涂料与涂装,1993(3).
作者姓名:张嘉铭  刘德铮  王瑛  肖詹蓉  李万臣  杨景芳  周云冲  傅惠兰  丁兆松  侯启明  关瑛  祖涛  周安群  赵金锁  凌国荣
作者单位:长春生物制品研究所,北京生物制品研究所,长春生物制品研究所,北京生物制品研究所,北京生物制品研究所,长春生物制品研究所,上海生物制品研究所,成都生物制品研究所,武汉生物制品研究所,中国药品生物制品检定所,中国药品生物制品检定所,中国药品生物制品检定所,浙江省卫生防疫站,浙江省余杭县卫生防疫站,浙江省余杭县卫生防疫站
摘    要:用50L发酵罐培养百日咳菌,经硫酸铵盐析法提取保护性抗原,戊二醛解毒后,与白喉、破伤风类毒素及Al(OH)_3配合制成的吸附精制百白破制剂(APDT),质量符合规程要求。给3~5月龄婴幼儿接种后全身和局部副反应很低,与现行吸附百白破制剂(WPDT)有非常显著性差异。免后血清中抗-PT和抗-FHA抗体均有显著增长,与WPDT制剂组相比,APDT的抗-PT和抗-FHA抗体增长更为显著。APDT免后抗白喉、抗破伤风抗体滴度均超过保护水平。本制剂的质量及免疫效果均达到了国外同类产品水平。

关 键 词:吸附精制百白破制剂  副反应  抗-PT  抗-FHA

Characteristic and Clinical Observation of the APDT prepared with Acellular Pertussis Antigens
Zhang Jiaming Changchun Institute of Biological Prodncts,Changchun.Characteristic and Clinical Observation of the APDT prepared with Acellular Pertussis Antigens[J].Chinese Journal of Biologicals,1993(3).
Authors:Zhang Jiaming Changchun Institute of Biological Prodncts  Changchun
Abstract:The protective antigens to pertussis were extracted from the culture of Bordetella pertussis in a 5OL fermenter by the ammonium sulfate salting out method. After detoxification with glutaraldehyde, the antigens were mixed with diphtheria, tetanus toxoid and A1 (OH)_3. The quality of adsorbed purified pertussis and diphtheria and tetanus vaccine (APDT) prepared by this method could meet the Chinese Requirements for the Biological Products. Being administered to infants aged 3~5 months, the APDT could cause mild local and systemic adverse reactions. There was significant difference between the extent of adverse reactions of APDT and current WPDT. The GMTs of anti-PT and anti-FHA in serum of infants administered with APDT were significantly higher than those administered with WPDT. Both the titers of antibodies to diphatheria and tetanus of infants administered with APDT were above protective level. It suggested that the quality and immunogenicity of the APDT reached the level of same products from abroad.
Keywords:Adsorbed purified pertussis  diphtheria and tetanus vaccine Adverse reaction Anti-PT Anti-FHA  
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